The Cardiovascular Research Foundation

New York City, NY, United States

The Cardiovascular Research Foundation

New York City, NY, United States

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News Article | May 12, 2017
Site: www.eurekalert.org

CRF meeting covering the latest in transcatheter valve therapies will celebrate its 10th Anniversary June 14-17 in Chicago The agenda for the TVT (Transcatheter Valve Therapies) is now available online: http://www. . TVT 2017 is a practical three-day course featuring the latest research and state-of-the-art techniques for transcatheter aortic and mitral valve therapies. For 10 years, TVT has provided healthcare professionals with the latest advances, tools, and techniques for the treatment of valvular heart disease using nonsurgical procedures. Some of the noteworthy sessions include: 10-Year Anniversary - Structural Heart Disease and the Evolution of Transcatheter Valve Therapy Thursday, June 15, 2017; 8:00 AM - 8:50 AM Provides an overview of the rapid evolution of transcatheter valve therapies including discussions on guidelines and the impact of therapies on the global burden of heart failure. Covers take-home lessons for clinicians on the latest guidelines for managing aortic valve disease, a snapshot of clinical practice in the European Union, the relationship between TAVR procedure volumes and clinical outcomes, the emergence of TAVR programs in Japan, and other topics. Includes an overview and critical appraisal of REPRISE III, how clinical and anatomic factors determine TAVR device selection, and the safety and effectiveness of cerebral embolic protection during TAVR. Closely examines TAVR trials in intermediate-risk aortic stenosis patients (SURTAVI, PARTNER 2a/S3i), in heart failure patients with moderate aortic stenosis (TAVR UNLOAD), and asymptomatic severe aortic stenosis (EARLY TAVR). Covers leaflet thrombosis and thickening, adjunctive pharmacotherapy, hemodynamic trends, and other topics. Valvular heart disease affects a large number of people who require diagnostic procedures and long-term management. Many patients have no symptoms, but for others, if not treated, advanced heart valve disease can lead to heart failure, stroke, blood clots, or death due to sudden cardiac arrest. Traditionally, valvular heart disease has been treated with surgical repair or replacement. Over the last several years, there have been important advances in concepts, tools, techniques, and patient selection using nonsurgical procedures. Transcatheter valve intervention offers the potential to reduce the procedural morbidity, mortality, and costs of surgical valve replacement or repair while accelerating patient recovery. The course directors for TVT 2017 are: Media may apply for registration by emailing jromero@crf.org. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. For more information, visit http://www. .


News Article | May 9, 2017
Site: www.eurekalert.org

NEW YORK - May 9, 2017 - The Cardiovascular Research Foundation (CRF) will hold a free seminar, "Broken Hearts: Living with Heart Failure," on Tuesday, June 6, 2017 for heart failure patients and caregivers at NewYork-Presbyterian Hospital. The seminar, part of a series of Mini-Med Schools conducted by the CRF Women's Heart Health Initiative, will focus on providing both patients and caregivers a deeper understanding of heart failure, its symptoms, and treatment options. Heart failure occurs when the heart cannot pump enough blood and oxygen to support other organs in the body. According to the American Heart Association, the number of people diagnosed with heart failure is increasing and is projected to rise 46% by 2030, resulting in more than 8 million people living with the disease. "This rapid rise in heart failure rates inspired the CRF Women's Heart Health Initiative to educate both men and women on this important subject," said Nisha Jhalani, MD, Director of the CRF Women's Heart Health Initiative and Director, Clinical and Educational Services for the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center. "Our goal is to have leading experts share their knowledge and provide attendees with the tools they need to take better care of themselves and their loved ones." "We hope to empower patients and their caregivers to take ownership of their health so that they can lead full and active lives," said Melana Yuzefpolskaya, MD, Associate Medical Director of the Cardiac Assisted Device Program at NewYork-Presbyterian Hospital/Columbia University Medical Center. "We want to motivate them to work closely with their physicians to follow treatment plans and closely track their symptoms to better manage their heart failure." The program will include the following presentations from renowned experts in the field: Nisha Jhalani, MD Director, CRF Women's Heart Health Initiative Director, Clinical and Educational Services, Center for Interventional Vascular Therapy, NewYork-Presbyterian Hospital/Columbia University Medical Center Assistant Professor of Medicine, Columbia University Medical Center For more information and to register, visit: http://www. . The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. For more information, visit http://www. . The CRF Women's Heart Health Initiative was founded to help reduce gender disparity in cardiovascular care using a two-pronged approach: advocating for increased female representation in clinical trials and raising awareness about women and heart disease through Mini-Med School educational seminars. For more information, visit http://www. .


News Article | July 17, 2017
Site: www.eurekalert.org

Media registration is open online for TCT 2017 (Transcatheter Cardiovascular Therapeutics), the annual Scientific Symposium of the Cardiovascular Research Foundation (CRF). TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine, attracting nearly 12,000 attendees from 90 countries all over the world. For the first time, TCT will be held in Denver, Colorado. Denver is a vibrant, active city at the base of the Colorado Rocky Mountains known for its stunning natural beauty, a thriving cultural scene, and award-winning dining. Every year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. TCT 2017 will also highlight state-of-the-art techniques and hands-on training, as well as high-definition live case transmissions. To learn more about the conference, please visit http://www. . Heart disease remains the leading cause of death worldwide. Every year, the discoveries made through hundreds of studies and late breaking trials presented at TCT lead to advancements in new medicines and devices that ultimately lead to improved care for patients with heart disease. Media may apply for registration by visiting: http://www. Details on required press credentials can be found at: http://www. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 29th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .


News Article | July 21, 2017
Site: www.eurekalert.org

NEW YORK - July 21, 2017 -The Cardiovascular Research Foundation (CRF) is pleased to announce that the first issue of Structural Heart: The Journal of the Heart Team is now available online. Structural Heart is an international, peer-reviewed journal focusing on diagnosing and treating diseases of the heart valves, myocardium and great vessels, as well as congenital heart disease, and the importance of the Heart Team in this process. The journal covers topics such as diagnostic techniques, percutaneous interventional procedures, cardiovascular surgery, drug treatment, findings from the laboratory, and clinical trials. "Structural heart disease is one of the most rapidly growing areas within cardiology and the source of some of the most exciting research and clinical advances in the field," said Anthony N. DeMaria, MD, Editor-in-Chief of the Journal and the Judith and Jack White Chair in Cardiology and Founding Director of the Sulpizio Cardiovascular Center at the University of California, San Diego. "The combination of increasing medical need coupled with the availability of innovative new therapies have propelled this field forward, and up until this point there has largely been a void in medical publications devoted to this topic. We hope that Structural Heart will fill that void." Led by a distinguished Editorial Board of recognized international experts in the field, Structural Heart is dedicated to disseminating the latest research and information to members of the Heart Team, as well as the wider medical community interested in structural disorders. "The emergence of structural heart disorders as a prominent part of cardiovascular practice has fostered collaboration among various professional disciplines involved in the care of these patients," said Ori Ben-Yehuda, MD, Deputy Editor of the Journal and Executive Director of the CRF Clinical Trials Center (CTC). "The field continues to be fueled by new, more accurate non-invasive diagnostic assessment, breakthrough interventional and surgical therapy, and the benefit of team decision-making and collaboration. It is our hope that Structural Heart will be a valuable addition to medical literature and an important source of information for Heart Teams around the world." The first issue of Structural Heart features the following articles: A New Home for Structural Heart Disease A. N. DeMaria and O. Ben-Yehuda Bicuspid Aortic Valve Disease: New Insights A. C. T. Ng et al. The 2017 ACC/AHA Updated Valve Guidelines Regarding Mitral Regurgitation: The Guidelines Get it Right P. A. Grayburn et al. Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses: Insights from the PARTNER II Valve-in-Valve Registry on Utilizing Baseline Computed-Tomographic Assessment D. Dvir et al. Cardiac Unloading with an Implantable Interatrial Shunt in Heart Failure: Serial Observations in an Ovine Model of Ischemic Cardiomyopathy N. L. Eigler et al. Left-to-Right Interatrial Shunting: A Novel Treatment for Heart Failure in Ischemic Cardiomyopathy T. P. Vahl A Paradox between LV Mass Regression and Hemodynamic Improvement after Surgical and Transcatheter Aortic Valve Replacement A. Kadkhodayam et al. The Left Ventricular Mass Regression Paradox following Surgical Valve Replacement: A Real Phenomenon or a Mathematical Glitch? P. Pibarot and M. A. Borger Percutaneous Ventricular Restoration Using the Parachute Device: The Parachute III Pressure-Volume Loop Sub-Study T. Patterson et al. Prognostic Value of Combination of Hemodynamic Parameters in Asymptomatic Aortic Valve Stenosis-The COFRASA/GENERAC Study T. Mathieu et al. Assessment and Prognostic Impact of Right Ventricular Function in Patients with Pulmonary Arterial Hypertension Undergoing Pulmonary Artery Denervation: Central Role of Global Right Ventricular Longitudinal Peak Systolic Strain S.-L. Chen et al. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve the survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. For more information, visit http://www. .


News Article | October 31, 2016
Site: www.eurekalert.org

NEW YORK - October 31, 2016 - The 28th annual Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) featured a number of first report investigations on novel stents that could become the next generation of bioresorbable stents in patients. "Bioresorbable stents have the potential to be greatly impactful in the treatment of coronary artery disease, and it is exciting to see these first report investigations of several new and novel stents advancing the technology forward," said Ajay Kirtane, MD, SM, a Co-Director of TCT. He is also Director of the Cardiac Catheterization Laboratories at NewYork-Presbyterian Hospital/Columbia University Medical Center and an Associate Professor of Medicine at Columbia University College of Physicians and Surgeons. "These results give us the first insights into their safety and efficacy, but larger randomized trials are necessary in order to establish their role in clinical practice." The FANTOM II study examined the safety and performance of native coronary artery stenting using the radiopaque desaminotyrosine polycarbonate-based sirolimus-eluting bioresorbable vascular scaffold (Fantom). The primary endpoint was the incidence of major adverse cardiac events (MACE) and late lumen loss (LLL) at six months. The prospective, multicenter trial enrolled a total of 240 patients across 28 clinical centers in eight countries. Patients were sequentially enrolled into two separate cohorts in which the only difference between them was a six-month (Cohort A) versus a nine-month angiographic assessment (Cohort B). The Cohort A group included a total of 117 patients and the Cohort B group included 123 patients. At six months, the incidence of MACE in both cohorts was 2.1% while the mean LLL in cohort A was 0.25 ± 0.40 mm. "Results of the FANTOM II trial demonstrate sustained performance and safety through six months of this novel bioresorbable scaffold," said Alexandre Abizaid, MD, PhD, Director, Interventional Cardiology at the Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil. "This preliminary clinical data indicates good acute performance, as well as enhanced device deliverability, minimal residual stenosis and acute recoil." The FANTOM II trial was funded by REVA Medical, Inc. Dr. Abizaid reported research grants and consulting fees/honoraria from Abbott Vascular, Boston Scientific, Elixir Medical, Medtronic and REVA Medical. Results from the first-in-man study of a novel thin-strut PLLA-based sirolimus-eluting bioresorbable vascular stent (MeRes100) showed that it was both safe and effective with no major adverse cardiac events (MACE) at six months. The MeRes100 is a low profile 100μm thin strut PLLA based BRS with a unique hybrid design featuring open cells at the center and closed cells at the edges resulting in improved trackability and access to side branches. It also has enhanced visibility with three circumferential radio opaque markers at each end. In this prospective, multicenter, single arm trial of MeRes100 BRS, a total of 108 patients (116 lesions) were enrolled at 16 Indian sites from May 2015 to April 2016. The primary end-point was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, ischaemia driven target lesion revascularization (ID-TLR), and ischaemia driven target vessel revascularization (ID-TVR) at six months. The secondary end-point was scaffold thrombosis at six months. The study found no MACE or stent thrombosis (ST) after the deployment of the scaffold up to six month follow-up. Quantitative coronary analysis (QCA) data at six months demonstrated very favorable in scaffold late lumen loss of 0.15±0.26mm. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) analysis showed no scaffold recoil and near complete strut coverage (99.3%) with neointima. "The innovative design of the MeRes100 scaffold developed in India addresses some of the limitations of currently available BRS. The MeRes-1 first-in-man study demonstrates that this new generation thinner strut sirolimus-eluting BRS is safe and effective at six months," said Ashok Seth, MBBS, FRCP, DSc, Chairman of the Fortis Escorts Heart Institute and Chairman of the Cardiology Council, Fortis Group of Hospitals in New Delhi, India. "These encouraging results provide the basis for further studies using wider range of length and sizes in more complex and larger patient population moving to a randomized pivotal trial against the second generation metallic Drug Eluting Stents (DES) by mid 2017." The MeRes-1 trial was funded by Meril Lifesciences, India. Dr. Seth reported receiving consulting fees/honoraria from Abbott Vascular and Meril Lifesciences. FUTURE-I was a prospective, single-center first-in-man study that sought to assess the feasibility, preliminary safety and effectiveness of a thin-strut (100-125μm) PLLA-based sirolimus-eluting bioresorbable scaffold (Firesorb BRS) in patients with single de novo coronary artery lesions. Between January and March 2016, a total of 45 patients with 45 target lesions were enrolled. After successful implantations of BRS, the 45 patients were randomized to two different follow-up cohorts in a 2:1 ratio. 30 patients in cohort 1 were required to undergo angiographic, IVUS, and OCT follow-ups at six and 24 months, respectively; and the others in cohort 2 will undergo imaging follow-ups at 12 and 36 months, respectively. The incidence of the primary endpoint, 30-day target lesion failure, was 0% with no scaffold thrombosis. At six months, the patient-oriented composite endpoint (PoCE: all death, all Ml, or any revascularization) in Cohort 1 was 3.3% (1). One patient underwent non-target vessel revascularization the day after the index procedure due to NSTEMI. The in-scaffold late loss was 0.15mm, the percentage of late recoil by IVUS was 0.76%, and the proportion of covered struts was 98.4% including 100% in seven patients by OCT, at six-month follow-up, respectively. "The six-month clinical, angiographic, IVUS, and OCT results of the FUTURE-I study demonstrated the feasibility and preliminary safety and efficacy of the thin-strut PLLA-based sirolimus-eluting Firesorb BRS in the treatment of patients with single de novo coronary lesions," said Bo Xu, MBBS, Director of Catheterization Laboratories at Fu Wai Hospital in Beijing, China. "Long-term imaging follow-up is needed to provide more information, and a pivotal randomized controlled trial (FUTURE-II) will be initiated soon." The FUTURE-I trial was funded by a research grant from MicroPort. Dr. Xu reported having no relevant conflicts of interest to disclose. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .


News Article | November 1, 2016
Site: www.eurekalert.org

Study indicates PCI of NIRS-defined lipid-rich plaque is safe and not associated with a greater incidence of adverse outcomes compared to PCI of non lipid-rich plaque WASHINGTON - November 1, 2016 - Two-year results from COLOR, the first large-scale multicenter prospective study of its kind, found that PCI on coronary artery lipid-rich plaque (LRP) detected by near infrared spectroscopy (NIRS) was not associated with subsequent major adverse cardiac events (MACE) compared to PCI of non-LRPs. Findings were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. The clinical impact of lipid-rich plaque (LRP) in patients with coronary atherosclerosis undergoing percutaneous coronary intervention (PCI) is poorly understood. Autopsy-based studies have suggested that LRP may be associated with increased PCI risk and subsequent events. Catheter-based near-infrared spectroscopy (NIRS) can identify the presence and extent of LRP in the coronary artery. Previous case reports, as well as small studies, have suggested an association between LRP as assessed by NIRS and peri-procedural outcomes after PCI. The COLOR registry was a prospective, multicenter, observational study designed to determine whether LRP detected by NIRS is associated with subsequent major adverse cardiac events (MACE). LRP was detected using an intracoronary NIRS imaging catheter that provides an assessment of coronary lipid distribution. Lipid core burden index (LCBI) was calculated as the fraction of yellow pixels within a scanned region multiplied by 1000. A total of 1,899 patients at 22 sites in the United States underwent NIRS during a clinically indicated catheterization procedure. The primary endpoint was MACE (a composite of cardiac death, myocardial infarction, stent thrombosis, revascularization and hospitalization) at two years. MACE occurring within two years were adjudicated by an independent clinical events committee and further classified as to whether they arose from the originally treated coronary segments (culprit) or untreated segments (non-culprit). The relationship between baseline LCBI and MACE at two years was also evaluated. Pre-intervention NIRS of treated coronary segment(s) was available in 1,168 patients (1,265 lesions), and NIRS of untreated segment(s) was available in 927 patients (1,072 lesions). The overall rate of MACE at two years was 14.1% for all patients, 6.0% related to the culprit lesion, 8.3% related to the non-culprit lesion related, and 2.4% indeterminate. Culprit lesion related MACE at two years was 6.3% for maxLCBI4mm "In this large-scale registry, non-culprit lesion related events were a little more common than culprit lesion post-PCI related events during two-year follow-up," said Giora Weisz, MD, Chairman of Cardiology at Shaare Zedek Medical Center in Jerusalem, Israel. "The results also indicate that PCI of NIRS-defined lipid rich plaques was safe, and was not associated with increased peri-procedural or long-term adverse outcomes compared to PCI of non-LRPs. Additional studies are needed to determine the clinical significance of NIRS-defined non-culprit LPRs." The COLOR trial was funded by InfraReDx, Inc. Dr. Weisz reported being a medical advisory board member for AngioSlide, AstraZeneca, Bayer, Calore, Corindus, Medtronic, Medivisor, MI Medical Incentives, TriSol, and Vectorius. He also disclosed grant/research support from AngioSlide, Boehringer Ingelheim, Corindus, and Matrizyme, as well as ownership in Filterlex. The results of the COLOR Trial will be presented on Tuesday, November 1 at 12:30 PM ET in the Main Arena (Ballroom, Level 3) at the Walter E. Washington Convention Center. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .


News Article | November 2, 2016
Site: www.eurekalert.org

Initial results of LAA closure device for stroke prevention in patients with atrial fibrillation demonstrate device safety and low rates of major adverse events WASHINGTON - November 2, 2016 - Initial results from the largest, prospective evaluation of a percutaneous transcatheter left atrial appendage (LAA) closure device (Amplatzer Amulet) for stroke prevention in patients with non-valvular atrial fibrillation show that the device has a high implant success rate and low major adverse events. Findings from the AMULET OBSERVATIONAL STUDY were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. The study enrolled 1,073 patients between June 2015 and September 2016 at 64 clinical sites in Europe, the Middle East, Asia, Australia and South America. 1,060 patients had device implantation, giving a technical success rate of 98.8%. Major adverse events (MAEs) within 7 days of implant included ischemic stroke (0.3%, n=3), pericardial effusion requiring intervention (0.5%, n=5), embolization (0.1%, n=1), and bleeding (0.9%, n=10). There were three deaths (0.2%) that occurred within seven days of attempted implant, two of which were adjudicated as procedure or device related, and one as unrelated to the device. At 1-3 month follow-up, the majority of patients were on antiplatelet therapy only and the CoreLab analyzed results of transesophageal echocardiography (TEE) showed a closure rate of 99%. "These results indicate that the Amplatzer Amulet is safe and associated with low rates of peri-procedural and early adverse events, as well as demonstrating high closure rates," said David Hildick-Smith, MD, from the Sussex Cardiac Centre, Brighton and Sussex University Hospitals in Brighton, United Kingdom. "In addition, antiplatelet therapy appears to be an effective treatment strategy post-implantation in the short-term. Additional long-term data is necessary to confirm these promising early findings." The AMULET trial was funded by St. Jude Medical. Dr. Hildick-Smith reported grant/research support and consulting fees/honoraria from St Jude Medical, Boston Scientific, Medtronic, Gore, Abbott, Occlutech and Edwards. The results of the AMULET OBSERVATIONAL STUDY will be presented on Wednesday, November 2 at 9:40 AM ET in the Main Arena (Ballroom, Level 3) in the Walter E. Washington Convention Center. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .


News Article | November 1, 2016
Site: www.eurekalert.org

WASHINGTON - November 1, 2016 - Final results from the RESPECT trial found that percutaneously closing a patent foramen ovale (PFO) using the Amplatzer PFO Occluder was superior to medical management in the prevention of recurrent ischemic stroke in patients who previously had a cryptogenic stroke. Findings were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. The U.S. Food and Drug Administration (FDA) recently approved the device for recurrent stroke prevention in patients with a PFO and history of cryptogenic stroke on the basis of these data. A PFO is a small hole between the atria that did not close completely early in life and which can allow a venous system clot to enter the left atrium and travel to the brain causing a stroke. Current guidelines call for medical management with anticoagulants or antiplatelet drugs for patients with PFO following a cryptogenic stroke. The RESPECT study examined the use of a device that closes the hole percutaneously versus medical management. From 2003 to 2011, a total of 980 subjects between 18 and 60 years of age were randomized to PFO Closure (N=499) or medical management (N=481) at 69 sites in the United States and Canada. The newest study results further extended follow-up, analyzing data from August 2003 through May 2016 for outcomes of recurrent ischemic strokes and recurrent ischemic strokes of unknown mechanism. The mean follow-up for the PFO group was 6.3 years and 5.5 years for the medical management group [total patient years: 3,141 (PFO) and 2,669 (medical management)]. Key findings showed that in the intention-to-treat cohort, there was a 45% relative risk reduction [HR 0.55 (95% CI: 0.305, 0.999) Log-rank 2-sided P-value: 0.046] in recurrent ischemic stroke for the PFO group and a 62% risk reduction [HR 0.38 (95% CI: 0.18, 0.79) Log-rank 2-sided P-value: 0.007] from recurrent ischemic stroke of unkown mechanism. An additional sensitivity analysis of all-cause stroke in patients under age 60 showed a 58% relative risk reduction [HR 0.42 (95% CI: 0.21, 0.83) Log-rank 2-sided P-value=0.010). Technical success (delivery and release of the device) of the PFO closure was 99.1% and procedural success (implantation without in-hospital serious adverse event) was 96.1%. In addition, there were no intra-procedural strokes, device embolization, device thrombosis or device erosion. Major vascular complications (0.9%) and device explants (0.4%) were also low. "The long-term results of the RESPECT trial show that PFO closure was more beneficial than medical management alone in reducing recurrent stroke," said David E. Thaler, MD, PhD, Chairman of the Department of Neurology, Tufts Medical Center and Tufts University School of Medicine, Associate Professor of Neurology, Tufts University School of Medicine and Director of the Comprehensive Stroke Center at Tufts Medical Center. "PFO closure can be considered an appropriate treatment option for patients with cryptogenic stroke to reduce their risk of recurrent stroke, but collaboration between a cardiologist and neurologist is important for proper patient selection." The RESPECT trial was funded by St. Jude Medical. Dr. Thaler reported consulting fees/honoraria from St. Jude Medical. The results of the RESPECT Trial will be presented on Tuesday, November 1 at 12:15 PM ET in the Main Arena (Ballroom, Level 3) at the Walter E. Washington Convention Center. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .


News Article | October 31, 2016
Site: www.eurekalert.org

WASHINGTON - October 30, 2016 - The large multinational randomized BIONICS study found that a novel ridaforolimus-eluting stent (BioNIR) was non-inferior to a zotarolimus-eluting stent (Resolute) for one-year clinical outcomes in a broad, less selected 'more comers' population. Results of this trial will be submitted to the FDA for U.S. approval of this novel drug-eluting stent. Findings were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. The ridaforolimus-eluting stent is a thin-strut (90 μm) cobalt chromium stent that elutes the rapamycin analogue ridaforolimus from a durable elastomeric polymeric coating. The multicenter randomized trial was conducted at 76 medical centers in the U.S., Canada, Europe, and Israel and enrolled a broad range of patients with coronary artery disease including patients with Non-ST Elevation MI (NSTEMI) as well as complex lesions. The primary endpoint was target lesion failure (TLF) at one year, the composite rate of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia driven target lesion revascularization (ID-TLR). Secondary endpoints were one year major adverse cardiovascular events (MACE), target vessel failure (TVF) and individual component endpoints, definite/probable stent thrombosis and procedural success. A total of 1,919 patients were randomized 1:1 to the BioNIR ridaforolimus-eluting stent (n= 958, 1,275 lesions) or Resolute zotarolimus-eluting stent (n=961, 1,277 lesions) stent. The baseline clinical characteristics were well balanced between the two arms, as were angiographic baseline characteristics with the exception of severe calcification (13.3% in the BioNIR group vs. 10.5% in the Resolute group, P=0.03). The primary endpoint of TLF at one year was identical for both at 5.3% (P=0.98). In addition, the rates of cardiac death (0.5% vs. 0.2%, P=0.29), TV-MI (3.1% vs. 3.3%, P=0.81) and ID-TLR (3.0% vs. 2.4%, P=0.38) were similar. Definite/probable stent thrombosis was 0.4% (4/921) for the ridaforolimus-eluting stent and 0.6% (6/927) for the zotarolimus-eluting stent (P=0.75). Device success was 98.3% for the ridaforolimus-eluting compared to 99.5% for the zotarolimus-eluting stent (P=0.004). "One-year clinical outcomes from the BIONICS study clearly show that the ridaforolimus-eluting stent was non-inferior to the zotarolimus-eluting stent with identical target lesion failure rates," said principal investigator, David E. Kandzari, MD. Dr. Kandzari is Director of Interventional Cardiology and Chief Scientific Officer at the Piedmont Heart Institute in Atlanta, GA. "In addition, it had a low stent thrombosis rate with no events beyond 30 days." The BIONICS trial was funded by Medinol and designed and conducted by the CRF Clinical Trials Center in collaboration with Novella Clinical which provided site management. Dr. Kandzari reported grant or research support from Abbott Vascular, Boston Scientific, Medtronic, Biotronik, St. Jude Medical/Thoratec, and Ablative Solutions, and consulting fees/honoraria from Boston Scientific, Medtronic, Micell Technologies, and St. Jude Medical. The results of the BIONICS Trial will be presented on Sunday, October 30 at 9:40 AM ET in the Main Arena (Ballroom, Level 3) of the Walter E. Washington Convention Center. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .


News Article | October 31, 2016
Site: www.eurekalert.org

WASHINGTON - October 31, 2016 - A first-in-human study of a new polymer-free drug-filled stent, which provides controlled drug elution from an internal lumen, indicated non-inferior in-stent late lumen loss at nine-months compared with historical zotarolimus-eluting stent (Resolute) data. In addition, there was no binary restenosis, and a high degree of early stent strut coverage with minimal malapposition. Findings from the REVELUTION study were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. The study was also published simultaneously in JACC: Cardiovascular Interventions. A polymer-free metal surface stent that is capable of controlled antiproliferative drug elution may avoid the adverse effects of polymer-induced inflammation, thrombosis and non-uniformity, and could potentially allow for shorter durations of dual antiplatelet therapy. The polymer-free drug-filled stent (DFS) used in the study was designed to provide controlled and sustained drug elution from an internal stent lumen without a polymer coating. The DFS is made from a tri-layered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution. The study enrolled 100 patients with de novo coronary lesions 2.25-3.50 mm in diameter and length ? 27 mm in two 50-patient cohorts for angiographic, intravascular ultrasound, and clinical assessment at nine or 24 months, with optical coherence tomography (OCT) performed in a subset of 30 patients at multiple time periods. The primary endpoint was angiographic in-stent late lumen loss at nine months compared with historical data from the zotarolimus-eluting stent (Resolute) as a control. Fifty patients with 56 lesions were treated with DFS in the nine-month cohort. Researchers found in-stent late lumen loss was 0.26±0.28 mm for DFS and 0.36±0.52 mm for Resolute (Pnoninferiority binary angiographic restenosis rate was 0%. Median stent strut coverage by OCT was 91.4%, 95.6%, and 99.1% at one, three, and nine months, respectively. One non-Q-wave myocardial infarction occurred, with a nine-month target lesion failure rate of 2.1%. No stent thrombosis occurred. "At nine months, the polymer-free drug-filled stent (DFS) was safe and effective with high rates of early strut coverage and non-inferior late lumen loss compared with historical Resolute data," said Stephen G. Worthley, MBBS, PhD, Chief Medical Officer of GenesisCare in Alexandria, Australia. "This polymer-free stent may avoid polymer-associated adverse vascular responses potentially allowing for a shorter duration of dual antiplatelet therapy. However, larger controlled studies with long-term follow-up are required to demonstrate whether the favorable properties of DFS translate into improved event-free survival in patients with coronary artery disease." The REVELUTION trial was funded by Medtronic. Dr. Worthley reported consultant fees from St. Jude Medical and Medtronic. The results of the REVELUTION study will be presented on Monday, October 31 at 12:00 PM ET in the Main Arena (Ballroom, Level 3) at the Walter E. Washington Convention Center. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .

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